Trial · NCT00880464
Autologous Vaccination With Lethally Irradiated, Autologous Breast Cancer Cells Engineered to Secrete GM-CSF in Women With Operable Breast Cancer
NCT00880464, Phase 1, Completed, Dana-Farber Cancer Institute; results first posted 2021-11-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Autologous Vaccination With Lethally Irradiated, Autologous Breast Cancer Cells Engineered to Secrete GM-CSF in Women With Operable Breast Cancer. Trials, record NCT00880464. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00880464
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Autologous Vaccination With Lethally Irradiated, Autologous Breast Cancer Cells Engineered to Secrete GM-CSF in Women With Operable Breast Cancer
- NCT number
- NCT00880464
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 8 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Breast Cancer
- Interventions
- Autologous, Lethally Irradiated Breast Cancer Cells
- First posted
- 2009-04-13
- Last updated
- 2022-04-01
- Results first posted
- 2021-11-09
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Minimum Number of Vaccine Doses Created Using Participant Tumor Sample | 40 Months | Tumor samples were obtained via malignant effusion or a surgically accessible tumor nodule of 2 cm in greatest diameter. Tumor cells were processed to single cell suspension and transduced with adenoviral vector encoding human Granulocyte-macrophage colony-stimulating factor (GM-CSF). Then, the cells washed extensively and irradiated with 10,000 cGy. Over the next 14 days, sterility cultures were tested for endotoxin and mycoplasma contamination. Individual vaccine cell dose and number varied depending on the final cell yield from vaccine production. For stage II-III patients, the minimal dose was 1 x 10\^5 cells and the maximal dose was 4 x 10\^6 cells. For metastatic patients, the minimal dose was 1 x 10\^5 cells and the maximal dose was 1 x 10\^7 cells. |
| Primary | Number of Participants With Grade 3 or Higher Adverse Events | Up to 58 Months | Number of participants with grade 3 or higher adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. |
| Secondary | Median Follow-up Time by Survival Status | Up to 14 Years | Participants followed for survival status. Participants who were alive were noted as such as late as December 2020. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Minimum Number of Vaccine Doses Created Using Participant Tumor Sample | 40 Months | Vaccinations prepared for enrolled for vaccine administration population. | doses | NUMBER |
| PRIMARY | Number of Participants With Grade 3 or Higher Adverse Events | Up to 58 Months | Analysis population for adverse events is Treated population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Follow-up Time by Survival Status | Up to 14 Years | Clinical outcomes assessed for the treated population. | years | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Minimum Number of Vaccine Doses Created Using Participant Tumor Sample | Vaccine | 6 | doses | ||
| Number of Participants With Grade 3 or Higher Adverse Events | Vaccine | Grade 3 | 1 | Participants | |
| Number of Participants With Grade 3 or Higher Adverse Events | Vaccine | Grade 4 | 0 | Participants | |
| Number of Participants With Grade 3 or Higher Adverse Events | Vaccine | Grade 5 | 0 | Participants | |
| Median Follow-up Time by Survival Status | Vaccine | Alive | 9.88 | Full Range 9.76 to 9.99 | years |
| Median Follow-up Time by Survival Status | Vaccine | Dead | 6.24 | Full Range 1.16 to 8.49 | years |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stage II-III Breast Cancer Cohort | 7 | |
| Overall Study | COMPLETED | Stage II-III Breast Cancer Cohort | 7 | |
| Overall Study | NOT COMPLETED | Stage II-III Breast Cancer Cohort | 0 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Allergic Reaction | Immune system disorders | Vaccine | 1 | 7 | 1 |
| other | Alanine aminotransferase increased | Investigations | Vaccine | 1 | 7 | 1 |
| other | Aspartate aminotransferase increased | Investigations | Vaccine | 1 | 7 | 1 |
| other | General disorders and administration site conditions - Other, specify | General disorders | Vaccine | 1 | 7 | 1 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Vaccine | 2 | 7 | 3 |
| other | Fat atrophy | Skin and subcutaneous tissue disorders | Vaccine | 1 | 7 | 1 |
| other | Fatigue | General disorders | Vaccine | 7 | 7 | 17 |
| other | Fever | General disorders | Vaccine | 2 | 7 | 2 |
| other | Headache | Nervous system disorders | Vaccine | 2 | 7 | 3 |
| other | Anemia | Blood and lymphatic system disorders | Vaccine | 1 | 7 | 1 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vaccine | 5 | 7 |
| Total, other adverse events | Vaccine | 7 | 7 |
| Total, serious adverse events | Vaccine | 1 | 7 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35482127 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00880464
GET https://conductscience.org/api/trials/v1/NCT00880464/events?page=2